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Trial registered on ANZCTR


Registration number
ACTRN12612001239853
Ethics application status
Approved
Date submitted
20/11/2012
Date registered
23/11/2012
Date last updated
23/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inhaled verapamil in patients with pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)
Scientific title
A placebo controlled clinical trial on the efficacy of inhaled verapamil 10 mg stat administration in patients with chronic obstructive pulmonary disease (COPD) and pulmonary arterial pressure(PAP)>45 mmHg.
Secondary ID [1] 281568 0
Nil
Universal Trial Number (UTN)
Trial acronym
IVPHC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD) 287850 0
Condition category
Condition code
Respiratory 288206 288206 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1:(a) Intervention group - nebulised verapamil ( 4ml,10mg) (the dosing form that exist in the market ,is 2.5 mg/ml as an injectable solution) once only. ARM 2:(b)Placebo group (4ml of distilled water) once only.
Intervention code [1] 286090 0
Treatment: Drugs
Comparator / control treatment
placebo group (4ml of distilled water) once only
Control group
Placebo

Outcomes
Primary outcome [1] 288399 0
Nebulised verapamil used as a treatment agent is associated with a reduction of Pulmonary Arterial Pressure (PAP).
Patients will undergo transthoracic Echocardiographic examination with evaluation of systolic PAP by echocardiography equipment
Timepoint [1] 288399 0
at baseline and 1 hour after the intervention
Primary outcome [2] 288404 0
Evaluation of EF (Ejection Faction) by transthoracic echocardiography equipment
Timepoint [2] 288404 0
at baseline and 1 hour after the intervention
Primary outcome [3] 288405 0
Evaluation of RV (Right Ventricular) size and RV TAPSE (Tricuspid Annular Plane Systolic Excursion) by transthoracic echocardiography equipment
Timepoint [3] 288405 0
at baseline and 1 hour after the intervention
Secondary outcome [1] 300052 0
Nebulised verapamil used as a treatment agent is associated with a reduction of Spirometric Parameters (FEV1, FVC and FEV1/FVC) that evaluated by spirometry equipment
Timepoint [1] 300052 0
at baseline and 30 minutes after the intervention
Secondary outcome [2] 300053 0
Nebulised verapamil used as a treatment agent is associated with a reduction of O2 Saturation that evaluated by pulse oximetry.
Timepoint [2] 300053 0
at baseline and immediately after the intervention
Secondary outcome [3] 300054 0
Blood pressure is measured by blood pressure cuff because of possible hypotension as the side effect associated with the intervention.
Timepoint [3] 300054 0
at baseline and immediately after the intervention
Secondary outcome [4] 300066 0
Heart rate is measured because of possible bradycardia as the side effect associated with the intervention.
Timepoint [4] 300066 0
at baseline and immediately after the intervention

Eligibility
Key inclusion criteria
Patients with pulmonary arterial pressure (PAP)>45mmHg secondary to chronic obstructive pulmonary disease (COPD) and normal ejection fraction (EF) (> 40%).
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The treatment and control groups will remain blinded to the treating clinicians. The clinical trial assistant will be unblinded for the preparation of the daily treatments.
The treatment allocation was randomized by a pharmacy technician who is not directly involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4688 0
Iran, Islamic Republic Of
State/province [1] 4688 0
Tehran

Funding & Sponsors
Funding source category [1] 286354 0
Other
Name [1] 286354 0
National Research Institute for Tuberculosis and Lung Diseases (NRITLD)
Address [1] 286354 0
Shaheed Bahonar Ave, Darabad
TEHRAN 19569,P.O: 19575/154
Country [1] 286354 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Beheshti University, M.C.
Address
Evin Ave., Tehran, 19834
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 285143 0
Hospital
Name [1] 285143 0
Masih Daneshvari
Address [1] 285143 0
Shaheed Bahonar Ave, Darabad, TEHRAN 19569,P.O: 19575/154
Country [1] 285143 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288436 0
Masih Daneshvari Research Ethics Committee
Ethics committee address [1] 288436 0
Shaheed Bahonar Ave, Darabad, TEHRAN 19569,P.O: 19575/154
Ethics committee country [1] 288436 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 288436 0
Approval date [1] 288436 0
20/01/2012
Ethics approval number [1] 288436 0

Summary
Brief summary
We could not find any study that has examined the use of verapamil in PH secondary to COPD. The proposed study will provide scientifically valid data to date on whether nebulised verapamil (10 mg) is effective in these cases or not.
Trial website
NIL
Trial related presentations / publications
NIL
Public notes

Contacts
Principal investigator
Name 34970 0
Address 34970 0
Country 34970 0
Phone 34970 0
Fax 34970 0
Email 34970 0
Contact person for public queries
Name 18217 0
Fanak Fahimi
Address 18217 0
Shaheed Bahonar Ave, Darabad, TEHRAN 19569,P.O: 19575/154
Country 18217 0
Iran, Islamic Republic Of
Phone 18217 0
+98 21 20109503
Fax 18217 0
+98 21 20109503
Email 18217 0
fahimi@nritld.ac.ir
Contact person for scientific queries
Name 9145 0
Professor Mohammad Reza Masjedi
Address 9145 0
Shaheed Bahonar Ave, Darabad, TEHRAN 19569,P.O: 19575/154
Country 9145 0
Iran, Islamic Republic Of
Phone 9145 0
+98 21 20109991
Fax 9145 0
+98 21 20109503
Email 9145 0
mrmasjedi@nritld.ac.ir

No information has been provided regarding IPD availability
Summary results
No Results