Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01457170
Other study ID # 11/CARD/04
Secondary ID
Status Recruiting
Phase N/A
First received October 20, 2011
Last updated July 12, 2013
Start date January 2012
Est. completion date January 2014

Study information

Verified date July 2013
Source Golden Jubilee National Hospital
Contact Andrew J Peacock, BSc MPhil MD
Phone +44 (0)141 951 5497
Email apeacock@udcf.gla.ac.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of Apelin on the lung circulation. The investigators hypothesise that Apelin will relax the lung blood vessels and improve the pumping ability of the heart.


Description:

Apelin is an endogenous peptide with physiological actions in the cardiovascular system and is abundantly expressed in the pulmonary vasculature. Pre-clinical models and preliminary clinical data indicate that Apelin deficiency may mediate or contribute to the pathogenesis of pulmonary hypertension and heart failure. Apelin causes peripheral vasodilatation and increased cardiac contractility. The investigators will determine the effects of Apelin on the pulmonary circulation in 3 groups; healthy control, people with pulmonary arterial hypertension and people with pulmonary hypertension due to heart failure. Each subject will receive both Apelin infusion and saline placebo infusion in a crossover design. The infusions will be given in a random order which the subject and the investigator will be blinded to. The investigators hypothesise that Apelin will have more marked pulmonary haemodynamic effects than that observed in the systemic circulation. Moreover, the investigators propose that Apelin will have a marked vasodilatory effect on the human pulmonary vasculature and reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension or pulmonary hypertension due to left heart disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 63
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility PULMONARY ARTERIAL HYPERTENSION

Inclusion Criteria:

- Pulmonary Arterial Hypertension which is Idiopathic, Heritable, associated with connective tissue disease or associated with drugs/toxins

- mean pulmonary artery pressure >/= 25mmHg

- pulmonary capillary wedge pressure < 15 mmHg

- normal/reduced cardiac output

- stable

- WHO functional class II - IV

Exclusion Criteria:

- significant left ventricular dysfunction

- chronic lung disease (FEV1 < 60% or abnormal CT)

- chronic thromboembolic pulmonary hypertension

HEART FAILURE

Inclusion Criteria:

- stable on treatment for 3 months prior to study

- NYHA grade II - IV

- ejection fraction <35%, left ventricular end-diastolic diameter > 5.5 cm and/or shortening fraction < 20%

- Tricuspid regurgitant velocity >/= 3.0 m/s

HEALTHY VOLUNTEERS

Inclusion Criteria:

- mean pulmonary artery pressure < 25 mmHg

- tricuspid regurgitant velocity < 2.5 m/s

Exclusion Criteria:

- obstructive coronary artery disease

ALL SUBJECTS

Exclusion Criteria:

- bleeding diathesis

- women of childbearing potential without pregnancy test

- systolic blood pressure > 190 mmHg or < 100 mmHg

- malignant arrhythmias

- renal or hepatic failure

- haemodynamically significant valvular heart disease

- severe or significant co-morbidity

- pacemaker

- already taking part in another trial

- lack of informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Intervention

Drug:
Apelin
During right heart catheterisation, Apelin will be infused at 30, 100 and 300 nanomol/min for 5 minutes. Apelin will then be infused at 300 nanomol/min for a further 15 minutes while the subject exercises using a supine ergometer.
Saline (Placebo)
During right heart catheterisation, saline will be infused for 15 minutes while the subject rest and for a further 15 minutes while the subject exercises using a supine ergometer.
Saline (Placebo)
During right heart catheterisation, saline will be infused for 15 minutes while the subject rest and for a further 15 minutes while the subject exercises using a supine ergometer.
Apelin
During right heart catheterisation, Apelin will be infused at 30, 100 and 300 nanomol/min for 5 minutes. Apelin will then be infused at 300 nanomol/min for a further 15 minutes while the subject exercises using a supine ergometer.

Locations

Country Name City State
United Kingdom Royal Infirmary Edinburgh Edinburgh
United Kingdom Golden Jubilee National Hospital Glasgow
United Kingdom Hammersmith Hospital London

Sponsors (3)

Lead Sponsor Collaborator
Golden Jubilee National Hospital Imperial College Healthcare NHS Trust, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pulmonary vascular resistance We will measure the change in pulmonary vascular resistance after infusion of Apelin during right heart catheterisation 5,10,15 and 30 minutes after start of infusion No
Secondary Change in systemic vascular resistance We will measure the change in systemic vascular resistance during infusion of Apelin 5,10,15 and 30 minutes after start of infusion No
Secondary Change in Cardiac Output We will measure the change in cardiac output after infusion of Apelin during right heart catheterisation. 5,10,15 and 30 minutes after start of infusion No
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy