Combination therapy for pulmonary hypertension using racecadotril

Phase 2

Completed

• Conditions: Topic: Cardiovascular, Respiratory; Subtopic: Cardiovascular (all Subtopics), Respiratory (all Subtopics); Disease: Respiratory, Congenital Heart Disease and Pulmonary Hypertension; Circulatory System; Primary pulmonary hypertension

• Registration Number: ISRCTN96717546
• Lead Sponsor: niversity College London (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30761523 (added 03/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-28
• Study Completion: 2017-04-05
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. WHO Group I pulmonary hypertension (i.e. idiopathic, familial or associated with connective tissue diseases
2. 18-80 years old
3. Technically satisfactory routine right heart catheterisation (Step 1 only)*
4. On sildenafil (20-100 mg; t.i.d.)
5. Six minute walk distance of >150 m
6. No changes to PH specific therapies for 1 month
7. Not pregnant (women only). Women of child-bearing potential must have a negative pregnancy test within seven days prior to randomisation they must be willing to use an effective method of contraception (including hormonal or barrier method of birth control) from the time consent is signed until six weeks after treatment discontinuation.
8. Able to provide consent for the trial
* Technically satisfactory means that the PI or delegated physician is content that the patient is able to have the catheter in for longer and that the necessary trial information is able to be extracted.
9. Target Gender: Male & Female

Exclusion Criteria

1. Known sensitivity to racecadotril or its excipients
2. Clinical diagnosis of liver cirrhosis or ALT/AST >2 X ULN
3. Kidney disease with an eGFR of <50 ml/min
4. History of angioedema
5. Systolic blood pressure <85 mmHg
6. Known history of drug or alcohol abuse within six months of enrolment
7. Participation in a clinical study involving another investigational drug
8. Women who are breastfeeding
9. Patients taking ACE inhibitors
10.Any clinical condition for which the investigator would consider the patient unsuitable for the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified