Modulating Effects of Lisinopril on Sildenafil Activity in Pulmonary Arterial Hypertension(PAH)( MELISSA) (MELISSA)
![]() |
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: NCT01181284 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : February 7, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Pulmonary Arterial Hypertension |
Study Type : | Observational |
Actual Enrollment : | 24 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Modulating Effects of Lisinopril on Sildenafil Activity in PAH (MELISSA) |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Group/Cohort |
---|
Lisinopril
Participants will be randomized 2 to 1 to receive drug versus placebo.
|
- The primary aim of the pilot study is to assess feasibility and tolerability. [ Time Frame: 32 weeks ]
- Demonstrate tolerability of long-acting angiotensin-converting enzyme inhibitor (ACEI) therapy in this patient cohort [ Time Frame: 32 weeks ]
- Demonstrate whether long-acting angiotensin-converting enzyme inhibitor (ACEI) in Pulmonary Arterial Hypertension (PAH) pts on sildenafil modifies regulation of the genes. [ Time Frame: 32 weeks ]
- Demonstrate whether ACEI in PAH pts on sildenafil reduces N-BNP levels, a marker of disease severity [ Time Frame: 32 weeks ]
- Demonstrate whether ACEI in PAH pts on sildenafil has an effect on pulmonary gas exchange parameters (exhaled NO, Dm, Vc, DLCO). [ Time Frame: 32 weeks ]
- Obtain exploratory data regarding whether ACEI in PAH pts on sildenafil improves functional class and 6 minute walk distance. [ Time Frame: 32 weeks ]

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: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age 18-75
- World Health Organization (WHO) Group I PAH with prior documentation of peripheral vascular resistance (PVR) > 3 WU and wedge(PCW) 16 or less.
- WHO Functional Class I-III
- 6 minute walk distance 150-575 meters
- Women of child bearing potential must have a negative pregnancy test and be using effective contraception
- Receiving therapy with phosphodiesterase-5 inhibitor for PAH (sildenafil or tadalafil) for at least 3 months and with stable dose for at least 30 days
- If already receiving therapy with endothelin receptor antagonists must have been on therapy for at least 3 months and on stable dose for at least 30 days
Exclusion Criteria:
- Allergy or intolerance to captopril or other angiotensin converting enzyme inhibitors
- Systemic systolic blood pressure less than 100 mm Hg
- Therapy with prostanoids (iloprost, treprostinil, epoprostenol) within preceding 3 months
- Pregnant or breast feeding
- Creatinine > 2.0 mg/dl
- Potassium > 5.0 meq/dl
- Unable to provide informed consent
- TLC or VC <60% predicted
- Untreated obstructive sleep apnea
- LVEF < 40%
- Hb < 10 mg/dL

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): NCT01181284
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Robert P Frantz, MD | Mayo Clinic |
Responsible Party: | Robert P. Frantz, MD, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01181284 |
Other Study ID Numbers: |
08-001716 MELISSA |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | February 7, 2012 |
Last Verified: | February 2012 |
Pulmonary Arterial Hypertension (PAH) |
Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases |
Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |