Effects of Viagra on Heart Function in Patients With Heart Failure
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00781508 |
Recruitment Status :
Completed
First Posted : October 29, 2008
Results First Posted : June 23, 2014
Last Update Posted : July 2, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure Left Ventricular Dysfunction | Drug: sildenafil Other: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Single Dose Sildenafil in Heart Failure Patients Improves 6-minute Walk Test by a Reduction in Left Ventricular Filling Pressure |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | November 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: sildenafil
Effect of oral administration of a single dose of sildenafil 50 mg on left ventricular filling pressures as evaluated 1 hr after sildenafil administration in patients with heart failure
|
Drug: sildenafil
Changes in left ventricular filling pressure 1 hour after the administration of a single oral dose of sildenafil 50 mg.
Other Name: Viagra Other: Placebo Changes in left ventricular filling pressure 1 hour after oral administration of placebo |
Placebo Comparator: placebo
Inactive placebo prepared to mimic the appearance of sildenafil.
|
Drug: sildenafil
Changes in left ventricular filling pressure 1 hour after the administration of a single oral dose of sildenafil 50 mg.
Other Name: Viagra Other: Placebo Changes in left ventricular filling pressure 1 hour after oral administration of placebo |
- Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil [ Time Frame: Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil ]Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e
- The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg. [ Time Frame: Measured 1 hr after oral administration of sildenafil 50 mg ]A standardized course was used to determine the distance walked (meters) during a 6 min walk supervised by a nurse trained in performance of the test.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults with Class III congestive heart failure and impaired left ventricular systolic function.
- A prior BNP level ≥ 200 pg/mL.
- Previously documented systolic pulmonary artery pressure >40 mmHg.
- Clinically stable for a minimum of 6 weeks.
- Able to give informed consent,
Exclusion Criteria:
- Unable to give informed consent.
- Currently taking nitrates.
- A HF exacerbation within the past 6 weeks.
- Co-morbid conditions that could limit their walking.
- Have a resting systolic blood pressure < 110 mmHg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781508
United States, Ohio | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109 |
Principal Investigator: | Robert C Bahler, MD | MetroHealth Medical Center |
Responsible Party: | Robert Bahler, Cardiologist Professor of Medicine CWRU, MetroHealth Medical Center |
ClinicalTrials.gov Identifier: | NCT00781508 |
Other Study ID Numbers: |
MO1RR000080 Grant Number UL1 RR024989 ( Other Grant/Funding Number: CWRU-CTSC ) ULI RR024989 ( Other Grant/Funding Number: NIH/NCRR CWRU-CTSC ) |
First Posted: | October 29, 2008 Key Record Dates |
Results First Posted: | June 23, 2014 |
Last Update Posted: | July 2, 2014 |
Last Verified: | June 2014 |
heart failure, left sided ventricular dysfunction diastolic dysfunction sildenafil |
Heart Failure Ventricular Dysfunction Ventricular Dysfunction, Left Heart Diseases Cardiovascular Diseases Sildenafil Citrate |
Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |