Combined Antihypertensive Therapy and Sexual Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by LanZhou University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
LanZhou University
ClinicalTrials.gov Identifier:
NCT01238705
First received: October 12, 2010
Last updated: November 10, 2010
Last verified: November 2010
  Purpose

This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs.

The researchers hypothesize that:

  1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension.
  2. Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels.
  3. Oxidative stress decline after both combination regimens. Felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.

Condition Intervention Phase
Hypertension
Sexual Dysfunction
Drug: Felodipine add Irbesartan
Drug: Felodipine add Metoprolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension

Resource links provided by NLM:


Further study details as provided by LanZhou University:

Primary Outcome Measures:
  • Female Sexual Function Index (FSFI) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    The Female Sexual Function Index (FSFI) is a multidimensional self-report scale for assessing sexual function in women.The FSFI hase been validated in women with various sexual disorders,and in non-dysfunctional controls showing good discriminant validity,internal consistency,and test-retest reliability.

  • International Index of Erectile Function(IIEF) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    The 15-item International Index of Erectile Function (IIEF) was developed to diagnose the presence and severity of erectile dysfunction (ED).


Secondary Outcome Measures:
  • Change of Systolic Blood Pressure in 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.

    BP is measured using a calibrated standard mercury sphygmomanometer.After the patient has been seated for 15 minutes,sitting BP is measured 2 times at 1- to 2-minutes intervals,The mean of 2 sitting BP measurements is used as the sitting BP value for that visit;If the difference between the 2 measurements is over 5mmHg,BP should be measured again, and the average of 3 measurements will be taken.


  • Change of Systolic Blood Pressure in 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.

  • Change of Systolic Blood Pressure in 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.

  • Change of Systolic Blood Pressure in 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week

  • Change of Systolic Blood Pressure in 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.

  • Change of Systolic Blood Pressure in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week

  • Change of Diastolic Blood Pressure in 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week

  • Change of Diastolic Blood Pressure in 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week

  • Change of Diastolic Blood Pressure in 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week

  • Change of Diastolic Blood Pressure in 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.

  • Change of Diastolic Blood Pressure in 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.

  • Change of Diastolic Blood Pressure in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.

  • Serum Estradiol in 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use hemiluminescent radioimmunoassay to detect the level of estradiol in serum sample.

  • Serum Estradiol in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Serum Testosterone in 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use hemiluminescent radioimmunoassay to detect the level of testosterone in serum sample.

  • Serum Testosterone in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Serum MDA in 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Among many oxidative stress biological indicators,malondialdehyde (MDA),the secondary products of lipid peroxidation,is the most representative and most studied polyunsaturated fatty acid peroxidation.

    Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of MDA in serum samples.


  • Serum MDA in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Serum 8-OHdG in 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Reactive oxygen species (ROS) produced either endogenously or exogenously can attack lipid, protein and nucleic acid simultaneously in the living cells. In nuclear and mitochondrial DNA, 8-hydroxydeoxyguanosine (8-OHdG) is produced during DNA repair and its measurement be useful as a marker of DNA lesion.

    Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of 8-OHdG in serum samples.


  • Serum 8-OHdG in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Serum HNE in 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    4 - hydroxy-nonyl acid (HNE) is a strong toxicity end product of lipid peroxidation.

    Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of HNE in serum samples.


  • Serum HNE in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: April 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Felodipine,Irbesartan,Sexual Dysfunction Drug: Felodipine add Irbesartan

Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.

Irbesartan,150mg/day, Sanofi - Aventis Pharmaceutical company, Registration Number: H20080074.

Other Names:
  • Plendil
  • Aprovel
Active Comparator: Felodipine,Metoprolol,Sexual Dysfunction Drug: Felodipine add Metoprolol

Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.

Metoprolol Succinate,47.5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: J20050061.

Other Names:
  • Plendil
  • Betaloc

Detailed Description:

The effects of hypertension and its pharmacotherapy on sexual function are well known in men,although this topic remains unexplored in women.There is evidence suggests that some classes of antihypertensive drugs such as diuretics and beta-blockers have more negative impact on male sexual function than other classes such as calcium channel blockers(CCBs) and angiotensin-converting enzyme inhibitors(ACEI).Some data suggest that angiotensin Ⅱ antagonists(ARBs) not only do not exacerbate sexual function in males,but even improve it.

Treatment with multiple antihypertensive medications was often necessary to attain blood-pressure goals recommended by guidelines.More than two third of patients with 2 or 3 degree of essential hypertension require combination therapy at the beginning of treatment to avoid target organ damage and to minimize the accidence of adverse events.

CCBs were recommended by both JNC-7 and ESH / ESC 2007 hypertension guidelines as the basic for the treatment of hypertension.The purpose of this study is to compare the impacts of different CCB-based antihypertensive drugs combination on sexual behavior in both male and female patients with essential hypertension,thus provide evidences for physicians to increase patients adherence to the treatment regimens beside lowing blood pressure.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with essential hypertension.
  • Initial hypertension, or without taking any antihypertensive for at least one month.
  • Sexual active.

Exclusion Criteria:

  • Patients with secondary hypertension.
  • Patients with malignant hypertension, coronary heart disease, diabetes, a history of syncope, bradycardia (heart rate <45 beats / min), atrioventricular block(Ⅱ or Ⅲ degree), sick sinus syndrome, congestive heart failure, a history of cerebral vascular accidents, serious hepatic and kidney dysfunction, a history of serious mental illness, pregnant, taking oral exogenous estrogens (including contraceptives), hysterectomy, breastfeeding, a history of alcohol or drug abuse, having serious conflict with sexual partner, severity sexual dysfunction.
  • Patients refuse to answer questions, refuse to fill in the questionaires,or do not willing to take blood examination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238705

Contacts
Contact: Jing Yu, Professor +86 0931 8942076 yujing2304@126.com
Contact: Ruixin Ma, Doctor +86 13893102690 mrxdr@sina.com

Locations
China, Gansu
The Second Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China, 730000
Contact: Ruixin Ma, Doctor    +86 13893102690    mrxdr@sina.com   
Contact: Jing Yu, Professor    +86 13893607559    yujing2304@126.com   
Principal Investigator: Jing Yu, Professor         
Sub-Investigator: Ruixin Ma, Doctor         
Sponsors and Collaborators
LanZhou University
Investigators
Study Chair: Jing Yu, Professor The Second Hospital of Lanzhou University
  More Information

Publications:
WRITING GROUP MEMBERS, Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. Erratum in: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Véronique L]. Circulation. 2011 Oct 18;124(16):e425.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jing Yu, The Second Hospital of LanZhou University
ClinicalTrials.gov Identifier: NCT01238705     History of Changes
Other Study ID Numbers: 0709TCYA068
Study First Received: October 12, 2010
Last Updated: November 10, 2010
Health Authority: China: Ethics Committee

Keywords provided by LanZhou University:
Hypertension
Antihypertensive Agents
Combination
Sexual Dysfunction
Oxidative Stress

Additional relevant MeSH terms:
Antihypertensive Agents
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Metoprolol
Felodipine
Metoprolol succinate
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 31, 2014