| CTRI Number |
CTRI/2012/03/002514 [Registered on: 23/03/2012] Trial Registered Retrospectively |
| Last Modified On: |
01/03/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Pulmonary Hypertension Registry - An Observational Project |
|
Scientific Title of Study
|
Pulmonary Hypertension Registry - A Data Collection Project |
| Trial Acronym |
PH Registry |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naresh Trehan |
| Designation |
Chairman- Medanta Heart Institute |
| Affiliation |
Medanta, The Medicity |
| Address |
Medanta, The Medicity,
Sec- 38, Gurgaon.
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4141414 |
| Fax |
0124-4834111 |
| Email |
naresh.trehan@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Mehrotra |
| Designation |
Consultant- Medanta Heart Institute |
| Affiliation |
Medanta, The Medicity |
| Address |
Medanta, The Medicity,
Sec- 38, Gurgaon.
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4141414 |
| Fax |
0124-4834111 |
| Email |
rahul.mehrotra@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Mehrotra |
| Designation |
Consultant- Medanta Heart Institute |
| Affiliation |
Medanta, The Medicity |
| Address |
Medanta, The Medicity,
Sec- 38, Gurgaon.
Sonipat
HARYANA
122001
India |
| Phone |
0124-4141414 |
| Fax |
0124-4834111 |
| Email |
rahul.mehrotra@medanta.org |
|
|
Source of Monetary or Material Support
|
| Investigator Driven Registry -At Hospital Site |
|
|
Primary Sponsor
|
| Name |
Medanta The Medicity |
| Address |
Sec- 38, Gurgaon, Haryana,India- 122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Mehrotra |
Medanta, The Medicity |
Third Floor, Medanta Heart Institute, Medanta The Medicity, Sec- 38, Gurgaon
Gurgaon
HARYANA |
9971698201
rahul.mehrotra@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients diagnosed with pulmonary hypertension, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Able to provide consent.
Newly or previously diagnosed as having Pulmonary Hypertension. |
|
| ExclusionCriteria |
| Details |
Not meeting inclusion criteria. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality and morbidity due to Pulmonary Hypertension in Indian population |
More than 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time lag between onset of first symptom and initial diagnosis of pulmonary hypertension |
More than 2 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/12/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypothesis - Pulmonary Hypertension(PH) is a grave disease that affects the functional quality of the patients with high morbidity and mortality. The advent of new drugs and better understanding of pathophysiology has resulted in better outcomes. It is likely that available treatment will change the natural course of disease and perhaps prolongs survival.
Purpose - The purpose of the PH Registry is to study the natural course of pulmonary hypertension and response to disease modifying drugs in subjects visiting the Medanta PH Clinic.
|