Inhaled verapamil in patients with pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)
Phase 1
Recruiting
- Conditions
- Pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)Respiratory - Chronic obstructive pulmonary disease
- Registration Number
- ACTRN12612001239853
- Lead Sponsor
- Shahid Beheshti University, M.C.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients with pulmonary arterial pressure (PAP)>45mmHg secondary to chronic obstructive pulmonary disease (COPD) and normal ejection fraction (EF) (> 40%).
Exclusion Criteria
1.Pregnancy 2.Patients with previous known hypersensitivity to verapamil (any formulation or route of administration) 3. Patients with sepsis 4. Patients with dysrythmia or heart block (second degree and third degree). 5.Patients with COPD exacerbation 6.Any contraindication for verapamil 7.Presence of an end stage disease (cardiac, renal and hepatic) 8.Patients receiving another calcium channel blocker (CCB), sildenafil and bosentan .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ebulised verapamil used as a treatment agent is associated with a reduction of Pulmonary Arterial Pressure (PAP).<br>Patients will undergo transthoracic Echocardiographic examination with evaluation of systolic PAP by echocardiography equipment[at baseline and 1 hour after the intervention];Evaluation of EF (Ejection Faction) by transthoracic echocardiography equipment[at baseline and 1 hour after the intervention];Evaluation of RV (Right Ventricular) size and RV TAPSE (Tricuspid Annular Plane Systolic Excursion) by transthoracic echocardiography equipment[at baseline and 1 hour after the intervention]
- Secondary Outcome Measures
Name Time Method ebulised verapamil used as a treatment agent is associated with a reduction of Spirometric Parameters (FEV1, FVC and FEV1/FVC) that evaluated by spirometry equipment[at baseline and 30 minutes after the intervention];Nebulised verapamil used as a treatment agent is associated with a reduction of O2 Saturation that evaluated by pulse oximetry.[at baseline and immediately after the intervention];Blood pressure is measured by blood pressure cuff because of possible hypotension as the side effect associated with the intervention.[at baseline and immediately after the intervention];Heart rate is measured because of possible bradycardia as the side effect associated with the intervention.[at baseline and immediately after the intervention]