HypertensionNCT00172406
The Relation Between Serum Level of Amioterminal Propeptide of Type I Procollagen and Diastolic Dysfunction in Hypertensive Patients Without Diabetes Mellitus
An observational study of Hypertension, run by National Taiwan University Hospital.
Trial summary
In the present study, we assessed the relation between diastolic dysfunction and myocardial fibrosis in hypertensive patients without diabetes mellitus. A total of 20 medically treated ambulatory non-diabetic hypertensive patients with normal left ventricular (LV) systolic function were enrolled into this study. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- We enrolled 20 medically treated ambulatory, non-diabetic, hypertensive patients in this study.
Who cannot join
- Patients with abnormal liver functions, leukocytosis, elevated serum levels of C-reactive protein, systolic dysfunction (LV ejection fraction <50%) and LV hypertrophy due to etiologies other than hypertension were excluded from this study.
About this study
In the present study, we assessed the relation between diastolic dysfunction and myocardial fibrosis in hypertensive patients without diabetes mellitus. A total of 20 medically treated ambulatory non-diabetic hypertensive patients with normal left ventricular (LV) systolic function were enrolled into this study. Myocardial fibrosis was evaluated by serum concentrations of amino-terminal propeptides of type I and III procollagen (PINP and PIIINP). All patients underwent examinations of diastolic function by echocardiography and technetium-99m (99mTc) radionuclide ventriculography. There were 8 patients with PINP ≦53 μg/l (group 1) and 12 patients with PINP >53 μg/l (group 2). Patients in group 2 had significantly lower LV peak filling rate (PFR; 3.2 ± 0.3 vs. 2.5 ± 0.2 end-diastolic volume/s) and shorter time to PFR ( 257 ± 41 vs. 174 ± 22 ms). Besides, the group 2 patients also had lower right ventricle PFR (1.9 ± 0.2 vs. 1.5 ± 0.1 end-diastolic volume/s) and shorter time to PFR ( 221 ± 29 vs. 154 ± 29 ms). Echocardiographic parameters for LV diastolic dysfunction (E/A ratio of mitral flow, deceleration time of E flow, velocities of pulmonary venous flow [retrograde A wave, systolic /diastolic velocity ratio], isovolumetric relaxation time, Tei index) were all comparable between two groups. In multiple regression analysis, LV time to peak filling rate was the only parameter that independently predicted serum PINP level (p<0.05). In conclusion, elevated serum PINP level reflected LV diastolic dysfunction in hypertensive patients without diabetes.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yi-Lwun Ho, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172406
- Sponsor's protocol ID
- 9361700202
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Serum Level of Amioterminal Propeptide of Type I Procollagen and Diastolic Dysfunction in Hypertensive Patients Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00172406
- Acronym / sponsor ID
- 9361700202
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present study, we assessed the relation between diastolic dysfunction and myocardial fibrosis in hypertensive patients without diabetes mellitus. A total of 20 medically treated ambulatory non-diabetic hypertensive patients with normal left ventricular (LV) systolic function were enrolled into this study. Myocardial fibrosis was evaluated by serum concentrations of amino-terminal propeptides of type I and III procollagen (PINP and PIIINP). All patients underwent examinations of diastolic function by echocardiography and technetium-99m (99mTc) radionuclide ventriculography. There were 8 patients with PINP ≦53 μg/l (group 1) and 12 patients with PINP >53 μg/l (group 2). Patients in group 2 had significantly lower LV peak filling rate (PFR; 3.2 ± 0.3 vs. 2.5 ± 0.2 end-diastolic volume/s) and shorter time to PFR ( 257 ± 41 vs. 174 ± 22 ms). Besides, the group 2 patients also had lower right ventricle PFR (1.9 ± 0.2 vs. 1.5 ± 0.1 end-diastolic volume/s) and shorter time to PFR ( 221 ± 29 vs. 154 ± 29 ms). Echocardiographic parameters for LV diastolic dysfunction (E/A ratio of mitral flow, deceleration time of E flow, velocities of pulmonary venous flow [retrograde A wave, systolic /diastolic velocity ratio], isovolumetric relaxation time, Tei index) were all comparable between two groups. In multiple regression analysis, LV time to peak filling rate was the only parameter that independently predicted serum PINP level (p<0.05). In conclusion, elevated serum PINP level reflected LV diastolic dysfunction in hypertensive patients without diabetes.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- We enrolled 20 medically treated ambulatory, non-diabetic, hypertensive patients in this study.
Key exclusion criteria (1 listed)
- Patients with abnormal liver functions, leukocytosis, elevated serum levels of C-reactive protein, systolic dysfunction (LV ejection fraction <50%) and LV hypertrophy due to etiologies other than hypertension were excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Lwun Ho, MD, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2005.