Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Heart Failure With Reactive Pulmonary Hypertension Clinical Trial

— Sildenafil-HF  

Official title:

Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02304705
• Other study ID #: 14-0628-F3R
• Status: Terminated
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a double-blind, placebo controlled trial.

Description:

Patients will be screened at the time of a diagnositic Right Heart Catheterization. Patients will be selected based on pressures measured during this procedure, current medications, and current symptoms. At baseline a 6 minute walk test and quality of life questionnaire will be administered. Medical records will be reviewed and results of recent testing will be recorded. Qualifying participants will be randomized to receive 90 days of either placebo or sildenafil 20 mg three times a day. Randomized patients will be followed for safety and efficacy by phone and as otherwise clinically indicated.

At the end of the 90 day treatment period, patients will be evaluated via 6 minute walk, quality of life questionnaire, and other diagnostic tests as clinically indicated. Primary outcome will be change in the 6 minute walk distance. Secondary outcomes will be based on clinically available results such as change in heart pressures measured by right heart catheterization and echocardiogram.

At the end of the treatment period, providers and patients will be unblinded in order to optimize further treatment.

To achieve statistical significance, 64 patients will be enrolled and randomized.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Known chronic heart failure appropriately treated with Angiotensin converting enzyme (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated

• indication for right heart catheterization

• pulmonary artery mean pressure >25 mmHg

• pulmonary capillary wedge pressure > 15 mmHg

• pulmonary vascular resistance > 3 Wood units

Exclusion Criteria:

• hypersensitivity, allergy, or intolerable side effect to sildenafil

• history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt

• co-morbidities, limited exercise intolerance:

• morbid obesity (BMI >40)

• COPD with oxygen dependence

• severe peripheral vascular disease with intermittent claudication

• status post amputation of lower extremity at any level

• severe degenerative joint disease preventing normal walking

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reactive Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Sildenafil
20 mg three times daily by mouth for 90 days
• Placebo
One capsule three times daily by mouth for 90 days

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Maya Guglin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Right Ventricular Function	Right ventricular function will be measured using tricuspid annular plane systolic excursion via two dimensional apical four-chamber echocardiography. Data will be collected at baseline and after 90 days of treatment	Baseline and 90 day
Other	Change in Cardiac Output Relative to Body Surface Area (Cardiac Index)	cardiac output will be calculated by multiplying stroke volume by heart rate. Cardiac index will be calculated by dividing cardiac output (Liters/minute) by body surface area (meters squared). Data will be collected at baseline and the end of treatment (90 days)	Baseline and 90 days
Other	Change in Pulmonary Vascular Resistance	Pulmonary vascular resistance will be determined by right heart catheterization. Data will be collected at baseline and at the end of treatment (90 days)	Baseline and 90 days
Other	Change in Blood Pressure	through standard cuff method, participants will have blood pressure measured to determine systolic and diastolic blood pressure as well as mean arterial pressure. data will be collected at baseline and 90 days.	Baseline and 90 days
Primary	Change in Exercise Tolerance	In a controlled laboratory environment, participants will be asked to walk on a treadmill as fast as they can for 6 minutes. The test will be conducted at baseline and after 90 days of treatment. Data will be presented as the change in distance (in feet) walked in 6 minutes between baseline and treatment.	Baseline and 90 days