Measurement of Endothelial Function and Cardiac Output: New Methods

Hypertension Clinical Trial

Official title:

Pilot Study: Analysis of Endothelial Function Through Circulating Endothelial Cells and Puls-amplitude-tonometry and of Non-invasive Measurement of Cardiac Output on Exertion in Patients With Heart Failure, Pulmonary Hypertension, Arterial Hypertension and Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299960
• Other study ID #: ENDO-CEC
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: June 9, 2016
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The main purpose of this study is to analyse test-retest-reliability of functional quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial hypertension and diabetic nephropathy. In the same group, test-retest-reliability of circulating endothelial cells as well as test-retest reliability of non invasive cardiac output Monitoring will be observed and analysed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinically stable for the last 4 weeks (not for HFrEF: 7 days)

• Signed consent form

HFpEF:

• Baseline-Echocardiography:

• hospitalization <= 12 months with diagnosis heart failure and E/E' > 8 or E' < 8 cm/s or

• BNP >= 100pg/ml or NT-proBNP >= 300pg/ml in the last 6 months or

• LAVI > 28 ml/m² and E/E' > 8 or E' < 8cm/s or PAPsys > 40mmHg and E/E' > 8 or E' < 8 cm/s

• Possibility to take part in cardiac stress test

• Heart failure NYHA I-III

• Sinus rhythm

• Max. O2-uptake on exertion < 20ml/kgBW/min

HFrEF

• HFrEF due to ischemic or non-ischemic reasons

• NYHA I-III

• Individually optimized and stable pharmacological therapy (including beta-blocker, ACE-Inhibitor, AT1-antagonist, aldosterone-antagonist)

• EF <=45%, Simpson Biplan PH

• NICE-Classification 2013 I/II

• PAH >= 25 mmHg

• Precapillary PAH: Wedge-pressure <= 15 mmHg, CO normal or low

• Postcapillary PAH: Wedge-pressure >= 15 mmHg, CO normal or low

Diabetic nephropathy:

• Diabetes mellitus Type 2 with oral or Insulin therapy and one or more of the following:

• Diabetic nephropathy has been diagnosed before (anamnesis)

• Macroalbuminuria: Urine Albumine/Creatinine-ratio > 300mg/g Creatinine (>34mg/mmol) in 2 out of 3 tests of Urine in the morning and GFR <90ml/min/1.73m² (CKD-EPI)

• Microalbuminuria: 30-300mg/g Creatinine (>=3.4 mg/mmol but <34mg/mmol) tested as above and GFR < 90 ml/min/1.73m² and diabetic retinopathy

AH:

• Hypertension diagnosed at least 6 months except structural heart disease: EF > 55% and no sign of HFpEF

• No symptoms of coronary heart disease

• Possibility to take part in cardiac stress test

• Stable pharmacologic therapy of Hypertension for at least 4 weeks

• Systolic blood pressure <140 mmHG during Screening

Exclusion Criteria:

• Patient incapable of contracting

• Angina pectoris > CCS II

• Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass

• Myocardial infarction in the last 3 months

• Stroke in the last 3 months

• Valvular heart disease > II°

• Cardiomyopathy due to Infiltrate/hypertrophic obstruction (e.g. HOCM, Amyloidosis)

• Congenital complex heart disease

• Active myocarditis

• Significant lung disease

• Significant Cardiac dysrhythmia

• Scheduled changes in medication during time of study

• (Scheduled) heart transplant

• Cardiac resynchronisation therapy over the last three months

• ICD/Pacemaker-implant in the last 4 weeks

• Uncontrolled Hyper/Hypotension (>180mmHg, <95mmHg)

• Patient taking part in Rehabilitation program

• Diagnosed Malignant disease or disease with life expectancy < 1 year

• Anemia with Hb<10mg/dl

• Untreated significant thyroid disease

HFpEF, Hypertension and PH:

• Patient incapable of cardiac stress test (e.g. because of orthopedic Problems)

• Significant changes in cardiovascular Status over the two weeks of study

• Instable cardiopulmonary Status over the last four weeks

HFrEF:

• I.v. Treatment with inotropic drug or diuretic in the last 7 days before Screening

• Myocardial infarction in the last 4 weeks

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Heart Failure
• Hypertension
• Hypertension, Pulmonary
• Kidney Diseases

Intervention

Device:
• Endo-PAT
Analysis of endothelial function through pulse-amplitude-tonometry
• NICOM
Non-invasive measurement of cardiac output

Locations

Country	Name	City	State
Germany	Charite Universitaetsmedizin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Bayer, Health Twist GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest-reliability EndoPAT		2 weeks	No
Secondary	Test-retest-reliability circulating endothelial cells		2 weeks	No
Secondary	Test-retest-reliability NICOM		2 weeks	No
Secondary	Correlation: Cardiac Output on exertion and cardiopulmonary exercise test and 6 Minute Walking test		2 weeks	No
Secondary	Correlation: circulating endothelial cells and EndoPAT and endothelial function	will include the molecular diagnostic of circulating endothelial cells	2 weeks	No
Secondary	Variability of biomarkers of myocardiac remodelling and of cardiorenal syndrome		2 weeks	No
Secondary	Correlation cardiac Output on exertion and echocardiography in HFpEF		2 weeks	No
Secondary	Clinical feasibility of circulating endothelial cells and EndoPAT		2 weeks	No